# Proposal Draft: Dalton pharma services — Small molecule TBD Manufacturing ## Scope of Work This proposal outlines the scope of services for Dalton pharma services for the TBD manufacturing and development support of a small molecule compound. **Target Scale:** 500g **Manufacturing Standard:** TBD ## Deliverables 1. **API synthesis** TBD synthesis of small molecule API at 500g scale. Includes process optimization, in-process controls, and batch record documentation. ## Proposed Timeline | Phase | Activity | Duration (est.) | |-------|----------|----------------| | 1 | Project Kickoff & Technology Transfer | 2-3 weeks | | 2 | API Manufacturing Campaign | 4-8 weeks | | 3 | Final Reports & Project Closure | 2-3 weeks | *Note: Timeline estimates are preliminary and subject to project kickoff discussions and resource availability.* ## Exclusions - Commercial-scale manufacturing - Sterile fill-finish operations (unless specifically scoped) - Regulatory filing preparation (unless specifically requested) - Clinical trial management and logistics ## Risks & Dependencies - Timeline dependent on timely receipt of starting materials and reference standards from the client - Analytical method transfer timeline assumes methods are partially developed - Scale near facility capacity limits; detailed capacity assessment required before commitment - Any changes to scope after project initiation may impact timeline and cost ## Assumptions - Client will provide compound characterization data, synthetic route, and any existing analytical methods within 2 weeks of project kickoff - Starting materials and reference standards will be supplied by the client or sourced by mutual agreement - Project changes require formal change control process ## Next Steps 1. Client confirmation of scope and deliverables 2. Project kickoff meeting to finalize technical details 3. Execution of Master Service Agreement and Quality Agreement 4. Detailed project plan and cost estimate to follow after kickoff --- *This is a preliminary proposal draft generated by the CDMO BD Triage System. Final pricing and detailed project plans will be provided after technical review and project kickoff discussions.*